FDA.reportPublic FDA data

Gen2

Primary DI
G277G2E12800
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2E1280
Catalog number
G2E1280
Device description
BECKMAN NASAL SPECULUM #1 SMAL
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G277G2E12800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags#

DUNS number
080402644
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840343727437Gen2G2N99753G2N997532026-04-23
00840343727567Gen2G2G37293G2G372932026-04-23
00840343727574Gen2G2N99755G2N997552026-04-23
00840343727581Gen2G2C62489G2C624892026-04-23
00840343727451Gen2G2N49254G2N492542026-04-22
00840343727468Gen2G2G37278G2G372782026-04-22
00840343727475Gen2G2G37279G2G372792026-04-22
00840343727482Gen2G2G35954G2G359542026-04-22
00840343727499Gen2G2C62277G2C622772026-04-22
00840343727505Gen2G2C62434G2C624342026-04-22
00840343727512Gen2G2N48672TCG2N48672TC2026-04-22
00840343727529Gen2G2N87457G2N874572026-04-22
00840343727536Gen2G2N99517G2N995172026-04-22
00840343727543Gen2G2G37282G2G372822026-04-22
00840343727550Gen2G2O917144G2O9171442026-04-22
00840343727291GEN2G2E901343G2E9013432026-04-16
00840343727307GEN2G2E901344G2E9013442026-04-16
00840343727314GEN2G2E901345G2E9013452026-04-16
00840343727321GEN2G2E900935G2E9009352026-04-16
00840343727338GEN2G2N52380G2N523802026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329837457N/ABLACK & BLACK SURGICAL, INC.EPY2026-03-05
G04360200G0GEIZBear-Ent, LLCEPY2026-03-05
G04360201G0GEIZBear-Ent, LLCEPY2026-03-05
G04360202G0GEIZBear-Ent, LLCEPY2026-03-05
G04360203G0GEIZBear-Ent, LLCEPY2026-03-05
G04360204G0GEIZBear-Ent, LLCEPY2026-03-05
00840329837464N/ABLACK & BLACK SURGICAL, INC.EPY2026-03-04
00198506088414ELMED INCORPORATEDELMED INCORPORATEDEPY2026-02-23
00810158218925PRINCETONPrinceton Medical Group, Inc.EPY2026-02-16
00190776415846MillenniumAvalign Technologies, Inc.EPY2026-02-04
G383WM7778700SURJEXSURJEXEPY2026-01-31
G383WM7778701SURJEXSURJEXEPY2026-01-31
G383WM7778702SURJEXSURJEXEPY2026-01-31
G383WM7778703SURJEXSURJEXEPY2026-01-31
04050659354647Brünings anastignatic aural magnifierSpiggle & Theis Medizintechnik GmbHEPY2026-01-21
00810158218437PRINCETONPrinceton Medical Group, Inc.EPY2026-01-07
00810158218444PRINCETONPrinceton Medical Group, Inc.EPY2026-01-07
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09348811116352INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-02
09348811116376INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-02
09348811116390INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-02
09348811148865INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-02
09348811116574INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811116628INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811116772INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811116789INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811116895INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811116901INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01
09348811117083INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-12-01